Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema

  • STATUS
    Recruiting
  • End date
    Jul 30, 2024
  • participants needed
    346
  • sponsor
    Mabwell (Shanghai) Bioscience Co., Ltd.
Updated on 19 April 2022

Summary

Phase III clinical study of the efficacy and safety of 9MW0813 and aflibercept (EYLEA®) in patients with diabetic macular edema (DME) in a multicenter, randomized, double-blind, parallel active-controlled study.

Description

This is a multi-center, randomized, double-blind, parallel controlled phase 3 clinical trial.

The primary objective is to compare the similarity of clinical efficacy of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.

The secondary objectives are to compare the similarity of safety, immunogenicity and pharmacokinetics of intravitreal 9MW0813 injection and aflibercept intraocular injection (EYLEA®) in DME patients.

Details
Condition Diabetic Macular Edema
Treatment Aflibercept, 9MW0813
Clinical Study IdentifierNCT05324774
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years old, gender is not limited
Diagnosed with type 1 or type 2 diabetes, and HbA1c≤10.0%
The visual impairment of the study eye was mainly caused by diabetic macular edema
OCT examination at screening and baseline, diabetic macular edema involving the fovea of the study eye, and central retinal thickness (CRT) ≥ 300 μm (using SD-OCT)
The best-corrected visual acuity (BCVA) of the study eye at screening and baseline measured using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart was between 73 and 24 letters (inclusive) (approximately equivalent to Snellen's visual acuity) score 20/40 to 20/320)

Exclusion Criteria

Active proliferative diabetic retinopathy (PDR) exists in the study eye
Structural damage to the fovea in the study eye, which may not improve BCVA after resolution of macular edema (eg, retinal pigment epithelial cell atrophy, subretinal fibrosis or scarring, significant macular ischemia, or organizing hard exudates) )
The study eye has any ocular disease or past medical history other than diabetic macular edema, and the investigator believes that it may affect the macular assessment or central vision (such as: cataract, retinal vascular occlusion, retinal detachment, macular traction, macular epiretinal membrane , macular hole, macular hemorrhage, preretinal fibrous proliferation involving the macula, various choroidal neovascularization)
The study eye has erythema of the iris, vitreous hemorrhage or traction retinal detachment
The study eye has poorly controlled glaucoma (defined as intraocular pressure ≥25mmHg after anti-glaucoma drug treatment)
The study eye has received or may have received glaucoma filtration surgery (such as: trabeculectomy, sclerectomy and non-penetrating trabecular surgery) during the study period
The study eye has received vitreoretinal surgery in the past
Aphakic (except intraocular lens) in the research eye
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note